Health Education: drug companies

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Drug Trial Information

I attended a brief lecture today that was presented by a statistician who works for a pharmaceutical company.  The statistician was Dr. Imogene Grimes.   As I have mentioned the FDA and its UK counterpart in several posts, as overseers of new drug applications and approvals, I wanted to share a couple of highlights from today's talk. This is not all new information (I have talked about the different phases before, for example) but it may be a more detailed explanation or in one case, a correction of past postings. I will start with the correction.  I thought in order to have a new drug approved, the new drug had to treat a condition that was not being treated at all, or treat a condition better than an existing drug, OR treat the condition similarly but with less side effects or less inconvenience.  That is NOT true - in the USA.  I do think that Europe has a different rule.  Dr. Grimes did say that one deterrent for not creating a new drug just to add it to the market is because doctor's don't like to switch patients to new drugs for no reason. What IS true is that the new drug has to show a benefit. The benefit has to be measurable.  This measurement has to be identified in the protocol.  The drug company has to say how the effect will be measured and what outcome from the drug is considered success.  For example, a new drug will lower cholesterol by at least 3 mg/dL which will be determined by a blood test.  Or a drug will reduce depression as measured by the average score a person gets on a test that measures feelings. The research has to include a risk to benefit analysis and proof that it is safe and effective.   We have talked about phase 1-3 trials before - but I think I left out a stage.  Actually I referred to Phase 1 as the non human participant part, but the stage that does not include human subjects is called the Pre Clinical phase. In the pre clinical stage, the drug is created and tested in the lab with test tubes, petree dishes and animals. Clinical trials are the ones that include people. Phase 1 includes healthy volunteers who do not have the condition that the drug is supposed to treat.  The scientists just want to know how the drug works in the body and what happens when different doses are tried. Phase 2 is the main efficacy stage - does it work?  Risk is also assessed in this stage, but efficacy is the main concern. The drug is tested in people who have the condition. Phase 3 is the large full scale trial that is specifically intended to capture the risk profile.  As Dr. Grimes said - chemicals always DO something - the drug does things we want it to do and things that we do not want.    Before a drug can be approved, the scientists also have to prove adequate exposure.  There have had to have been enough people in the various phases to assess the effect and risk.  There is a standard.  <ul><li>At least 100 people have had to been on the drug for at least a year,</li><li>between 300 and 600 have had to been on it for 6 months, and </li><li>1500 people have had to have had at least one dose.</li></ul>Monitoring of the drug continues as long as the drug is on the market.  The process of testing - pre clinical, phase 1-3 and FDA assessment can take 12-16 years and cost a billion dollars. New term: "biocreep" - the term for when less effective drugs get approved - some fault of the system when a drug does not have to be compared to a placebo. Types of Studies: A superiority study attempts to prove that the new (investigative) drug is better at treating a condition than a placebo. A non inferiority study is intended to show that the investigative drug is at least as good as an existing drug (for that condition).

Drug Trial Information

I attended a brief lecture today that was presented by a statistician who works for a pharmaceutical company. The statistician was Dr. Imog...

7:37 PM

Pay to Work

I am frustrated that I cannot locate one of my own posts!  Not too long ago I continued my reporting on doctors who are given stipends, incentives, gifts and fees by drug companies.  I have written about it many times.  <a href="http://yourhealtheducator.blogspot.com/2010/04/accountability.html">Here</a> is one of them, but not the most recent.  In the most recent, I directed you to this <a href="http://projects.propublica.org/docdollars/">webpage</a> as Propublica had released actual payment numbers on doctors in such a way as to allow you or I to look up a specific person. These are good things and they are having an impact according to a research study out of Mass General and Harvard Med School.  In this research, they asked physicians to complete a survey.  I must admit, it is hard to get a good response to surveys and researchers need large numbers in order to make associations and especially associations that can be applied to larger groups.  So - according to the popular press article I read from L. Tanner and the AP, 64% of the people sent a questionnaire responded.  The good news is that the medical community is setting guidelines and standards and the practice of wining, dining and paying doctors is easing. The GREAT irony is that those who completed the survey earned themselves 20 bucks.  This triggered me to write.  I recall speaking to a room full of physicians who were receiving a catered dinner and a couple hundred bucks for coming to this once a year meeting on how to treat tobacco dependence in their patients.  Yes, we spoke to them about Best Practices - how to use this technique called the 5As - Ask, Advise, Assess, Assist, Arrange. Another study has actually paid doctor's offices a monthly stipend of up to 500 dollars for doing their job (telling people to quit) and giving the researchers data on how many patients they advised to quit.  The point of the study is to see if money changes behavior as many doctors do not use the 5As and they have been around since 1998.  (if they think money changes behavior, why not just pay the smokers ) So, if obesity treatment and prevention is really to be tailored after all the successful tobacco strategies, we will soon be paying physicians to tell us we are fat. (to be fair, not all doctors need money to do their job and are quite good at assessing and treating tobacco dependence - it is just a shame when they all aren't)

Pay to Work

I am frustrated that I cannot locate one of my own posts! Not too long ago I continued my reporting on doctors who are given stipends, ince...

5:26 PM

Big Pharna Eats em Up

When you get a notion about something, you tend to stay on alert for any article that will support or debunk that notion. I have recently been expressing my thoughts on how Big Pharma is similar to Big Tobacco. Well, even I am surprised at how true my presumption appears to be. This was supported a few days ago by a headline regarding one big pharmaceutical company buying another. In fact, two companies have bought companies that were pretty big themselves and the profits for Big Pharma appear to be pretty consistent, just like tobacco. Merck bought Schering- Plough and Pfizer bought Wyeth. That would put Merck against Pfizer and GlaxoSmithKline. Also this week, the FDA noted that the labels on many drugs were misleading and did not tell consumers the whole story. Now I have cautioned you about commercials that tell you a drug or product or DIET PROGRAM was clinically tested, as that doesn't tell you anything, and I have also warned you about ads that say that people on a diet, for example, lost more weight than people not on it, because if it wasn't statistically significant, than it could be related to chance. But even pharmaceutical companies are guilty according to doctors speaking in the New England Journal of Medicine. One example they give is telling people that the drug is more effective than placebo. Ok, it is better than nothing. Is it better enough to change a disease outcome? Why does this make me think of Big Tobacco? Altria Group owns Philip Morris USA, maker of many top selling cigarettes, including Marlboro and Virginia Slims and US Smokeless Tobacco, AND John Middleton, which sells cigars and pipe tobacco. Philip Morris International sells some of the same brands of cigarettes abroad and has additional country specific brands, PLUS they just bought Swedish Match South Africa which sells smokeless tobacco and snus, Reynolds American owns RJ Reynolds which sells five of the top ten cigarette brands, including my old favorite, Winston as well as Conwood Co LLC which is the second largest smokeless tobacco company and sells roll your own tobacco and a company called Sante Fe which sells the American Spirit brand. I don't think I need to tell you how fraudulent and unscrupulous their tobacco advertising has been. So yeah, these are behemoths of companies with billions of dollars in revenue and people either desperate for the medication they sell to treat illnesses many times self perpetuated and people desperate for a product that they are addicted to and which is leading them down the road to having to rely on Big Pharma to get off the stuff or to stay alive or both. Cynicism is on the menu tonight - sorry

Big Pharna Eats em Up

When you get a notion about something, you tend to stay on alert for any article that will support or debunk that notion. I have recently b...

5:49 PM

The T stands for Testosterone!

Frustration with a TV commercial led me to spend much of Saturday afternoon learning about testosterone deficiency and treatment. First the frustration and then the scientific input. You may have noticed a commercial that talks about feeling lethargic and not yourself etc, with the voice over, "it may be LowT". It is a very cutesy, can it be cutesy and target men?, ad that is just another example of direct to consumer advertising for a medication. This is one of my top five pet peeves. I feel the same way about direct marketing anti-depressant medications, any medications really. The pharmaceutical companies have a product to sell and they cannot sell it if people don't have the condition it is intended to treat. Well it can be used to treat other conditions, but that is another story. They are in it to make back the money they spent on development and then to turn a profit. Now the drug company feels that it has to educate the public on the medical condition. Well, low testosterone is usually a matter of aging. It is also true that men who are overweight, sedentary, diabetic and who use tobacco are often in the group with low testosterone levels. It has not been said that lifestyle causes low testosterone levels, only that the condition is found to a higher degree in those situations. BTW, the actual term for low testosterone is NOT low T, but hypogonadism. That has a nice singsong ring to it doesn't it? Ok. The condition is real. I would hope that a well educated physician would know to evaluate a person for this if they had the symptoms. The condition does respond to treatment, of which there are several types. Mainly, injections, patches or gels. The oral treatment is not used in the this country due to risk of liver damage. The Low T commercial directs you to a website to learn about the condition, I direct you instead to the Cleveland Clinic website... <a href="http://my.clevelandclinic.org/services/testosterone_replacement_therapy/hic_testosterone_replacement_therapy.aspx">http://my.clevelandclinic.org/services/testosterone_replacement_therapy/hic_testosterone_replacement_therapy.aspx</a> The website the ad directs you to is copyrighted by Solvay Pharmaceuticals, Inc. This company sells a gel to treat low testosterone and it encourages you to ask your doctor about it. I was able to learn a little about the options and risks of all TRT (testosterone replacement therapy) by reading this article: Medical Progress: Risks of Testosterone-Replacement Therapy and Recommendations for Monitoring. Rhoden, Ernani Luis; Morgentaler, Abraham. Volume 350(5), 29 January 2004, pp 482-492 And in a Medscape article I was able to find a chart that compared blood levels of testosterone by treatment. I learned that the TRT patch and gels are similar and that the injections were able to get the level up higher but for shorter periods. The gel is the most expensive of the medications at about 300 dollars a prescription. An additional concern with the gel, which is not applied to the penis, but the arms, shoulders or stomach, is that it will get on someone else. Hormone therapy is not to be taken lightly. There is not a consensus on treating hypogonadism with hormone therapy as it was years after we treated women with estrogen therapy it became apparent that it caused cancer. My message to you today is to let the medical experts educate and treat, not the pharmaceutical companies.

The T stands for Testosterone!

Frustration with a TV commercial led me to spend much of Saturday afternoon learning about testosterone deficiency and treatment. First the ...

2:53 PM

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Drug Trial Information

Pay to Work

Big Pharna Eats em Up

The T stands for Testosterone!

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